• quality management system
• standard operating procedure
• class III implantable medical devices
• clinical investigation

Clinical Investigations (CIs) are studies in human subjects to demonstrate the safety and the clinical performance of a medical device. As manufacturer of Class III implantable medical devices, BellaSeno must conduct CIs to generate reliable clinical data to place the novel 3D-printed resorbable scaffolds on the European market. Every aspect of this complex process must be outlined in written quality procedures, enforcing a standardized process to ensure the success of a study. Standard Operating Procedures (SOPs) to conduct CIs have been developed in this thesis work, splitting the overall process into different phases before, during and after the beginning of the study. Considering that the company is interested in performing CIs in Europe, United States and Australia, the elaborated procedures are in compliance with EU MDR 2017/745, FDA and TGA Regulations. Together with the developed SOPs, original templates, forms, and checklists have been designed in this thesis work to support BellaSeno in the management of current and future CIs.